Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease
Biobehavioral Mechanisms of Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease
2 other identifiers
interventional
270
1 country
1
Brief Summary
Alzheimer's Disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) not only exact a heavy toll on patients, they also impose an enormous emotional, physical, and financial burden on unpaid, often family, caregivers. The strain of providing care for a loved one diagnosed with AD, often across several years, is associated with elevated depression risk and poorer overall health. Emotion regulation skills represent an ideal target for psychological intervention to promote healthy coping in ADRD caregivers. The project seeks to use an experimental medicine approach to test the efficacy and biobehavioral mechanisms of a novel, relatively brief, targeted, scalable, smartphone-based cognitive emotion regulation intervention aimed at improving psychological outcomes (i.e., reducing perceived stress, caregiver burden, and depressive symptoms) in ADRD unpaid primary caregivers as well as examine potential benefits of the caregiver intervention on quality of life in care recipients. Cognitive reappraisal is the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal can be operationalized via two primary tactics: psychological distancing (i.e. appraising an emotional stimulus as an objective, impartial observer) and reinterpretation (i.e., imagining a better outcome than what initially seemed apparent). The project will investigate the efficacy and underlying biobehavioral mechanisms of a novel, one-week cognitive reappraisal intervention in this population, with follow-up assessments at 2 weeks, 4 weeks, and 3 months. ADRD unpaid primary caregivers will be randomly assigned to receive training in either distancing, reinterpretation, or a no regulation natural history control condition, with ecological momentary assessments of self-reported positive and negative affect, remotely- collected psychophysiological health-related biomarkers (i.e., heart rate variability data) using pre-mailed Polar H10 chest bands, and health-related questionnaire reports. Distancing training is expected to result in longitudinal reductions in self-reported negative affect, longitudinal increases in positive affect, and longitudinal increases in HRV that are larger than those attributable to reinterpretation training and no-regulation control training.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2023
CompletedFirst Posted
Study publicly available on registry
July 17, 2023
CompletedStudy Start
First participant enrolled
September 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
April 16, 2026
April 1, 2026
3.6 years
April 10, 2023
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Self-reported negative affect
Self-reported negative affect data collected during completion of emotion regulation task via smartphone
During Sessions Day 1 - Day 7; this cycle is 7 days
Ecological momentary assessment of positive and negative affect
Ecological momentary assessment (EMA) of positive and negative affect collected during 4 daily afternoon EMA pings via smartphone
During Sessions Day 1 - Day 7; this cycle is 7 days
Heart rate variability
Heart rate variability measured via smartphone in conjunction with a Bluetooth-connected H10 Polar Chest Band. Change in heart rate variability assessed at the following timepoints:
Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Perceived stress
Perceived stress assessed via the Perceived Stress Scale on a scale of 0 to 4, with 0 indicating "Never" and 4 indicating "Very Often". A higher overall score on the stress scale indicates a worse outcome. Change in self-reports of perceived stress assessed at the following timepoints:
Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Caregiver burden
Caregiver burden assessed via the Caregiver Burden Scale on a scale of 0 to 4, with 0 indicating "Never" and 4 indicating "Nearly Always". The greater the total score, the worse the outcome. Change in self-reports of caregiver burden assessed at the following timepoints:
Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Caregiver quality of life
Caregiver quality of life assessed via the Caregiver Quality of Life Index on a scale of 0 to 4, with 0 indicating "Not at all" and 4 indicating "Very much". A higher overall score on the Caregiver quality of life index indicates a higher quality of life and better outcome. Change in self-reports of caregiver quality of life assessed at the following timepoints:
Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Depressive symptoms
Depressive systems assessed via the Center for Epidemiological Studies-Depression (CES-D) Depression Inventory on a scale of 0 to 3, with 0 indicating "Rarely or none of the time (less than 1 day)," and 3 indicating "Most or all of the time (5-7 days)". The higher the score on the CES-D Depression Inventory, the worse the outcome. Change in self-reports of depressive symptoms assessed at the following timepoints:
Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Difficulty in regulating emotion
Difficulty in regulating emotion will be assessed using the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF). There are 5 possible responses to a series of questions: almost never (0-10%), sometimes (11-35%), about half of the time (36-65), most of the time (66%-90%), almost always (91-100%). "Almost never" is the minimum score and "almost always) is the maximum score. Higher scores reflect a worse outcome or greater difficulty with emotion regulation. Change in self-reports of regulating emotions assessed at the following timepoints:
Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Positive and negative affect
Positive and negative affect assessed via the Positive and Negative Affect Schedule (PANAS) on a scale of 1 to 5, with a score of 1 indicating "Very slightly or not at all" and a score of 5 indicating "extremely". It is scored using two categories, a positive affect score and a negative affect score. Those with a higher positive affect and lower negative affect score have the most positive outcome. Change in self-reports of positive and negative affect assessed at the following timepoints:
Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Interpersonal regulation
Interpersonal regulation efficacy assessed via the Interpersonal Regulation Questionnaire on a scale of 1 to 7, with a score of 1 indicating "strongly disagree" and a scale of 7 indicating "strongly agree". A higher score on this questionnaire indicates a change in self-reports of interpersonal regulation assessed at the following timepoints:
Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Empathy
Empathy Assessed via the Interpersonal Reactivity Index (IRI) on a scale of 0 to 4, with a score of 0 indicating "does not describe me well" and a score of 4 indicating "describes very well". A higher score on this index indicates greater levels of empathy. In this study, the degree of empathy the individual scores does not correlate to a better or worse outcome. The Change in self-reports of empathy assessed at the following timepoints:
Initial training (Day 0), Day 7, Day 14, Day 28, and Month 3
Secondary Outcomes (21)
Reappraisal usage frequency
Initial training (Day 0)
Reappraisal usage frequency
Day 7
Reappraisal usage frequency
Day 14
Reappraisal usage frequency
Day 28
Reappraisal usage frequency
Month 3; this period one day long, 3 months after the initial visit)
- +16 more secondary outcomes
Study Arms (3)
Distancing
EXPERIMENTALParticipants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction via videoconference in which detailed instructions for implementation of the distancing strategy is explained (i.e. appraising an emotional stimulus as an objective, impartial observer).
Reinterpretation
ACTIVE COMPARATORParticipants will receive structured cognitive emotion regulation training from an experimenter during an approximately 10-minute interaction via videoconference in which detailed instructions for implementation of the reinterpretation strategy is explained (i.e. imagining a better outcome than what initially seemed apparent).
No regulation "Look Only"
NO INTERVENTIONThe No Regulation "Look Only" Control group will serve as a habituation and natural history control; they will see the same emotional images, but they will only be cued to look and respond naturally for all trials.
Interventions
The project will randomly assign Alzheimer's Disease or related dementia (AD/ADRD) unpaid primary caregivers to receive a brief course of reappraisal training using either psychological distancing or reinterpretation, or to a no regulation natural history control condition. In the Psychological Distancing group, participants will be asked to down-regulate negative emotion by reappraising an emotional stimulus as an objective, impartial observer.
The project will randomly assign Alzheimer's Disease or related dementia (AD/ADRD) unpaid primary caregivers to receive a brief course of reappraisal training using either psychological distancing or reinterpretation, or to a no regulation natural history control condition. In the Reinterpretation group, participants will be asked to down-regulate negative emotion by imagining a better outcome (when engaging with an emotional stimulus) than what initially seemed apparent.
Eligibility Criteria
You may qualify if:
- Healthy Adult Caregivers
- Unpaid primary caregiver of patient with Alzheimer's Disease/Alzheimer's Disease and Related Dementias (AD/ADRD)
You may not qualify if:
- Must be able to speak, read, and write in English
- Must have a smartphone. This represents any major iOS or Android-based smartphone. The smartphone will also be used for collection of ecological momentary assessment (EMA) data via SurveySignal.
- Must provide significant level of caregiving to their care recipient
- Must be at least minimally-stressed
- Cognitively Impaired Adults
- Must have diagnosed with Alzheimer's Disease/Alzheimer's Disease and Related Dementias (AD/ADRD)
- Must be the care recipient of the primary caregiver who is completing the study
- Must be able to understand and willing to complete a questionnaire and the consent form
- Must have minimum level of dementia symptoms
- Healthy Adult Caregivers
- Currently receiving psychotherapy that specifically addresses caregiver burden/distress or employs cognitive reappraisal as a major component
- Significant visual, auditory, or cognitive impairment that compromises their ability to understand and complete the task
- Has formerly participated in a study from our lab involving the same or essentially same design (e.g., former participants who provided pilot/preliminary data for this study)
- Cognitively Impaired Adults
- The care recipient does not wish to participate, and/or their caregiver does not want them to participate
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bryan Dennylead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Rice University
Houston, Texas, 77030, United States
Related Publications (9)
Denny BT, Ochsner KN. Behavioral effects of longitudinal training in cognitive reappraisal. Emotion. 2014 Apr;14(2):425-33. doi: 10.1037/a0035276. Epub 2013 Dec 23.
PMID: 24364856BACKGROUNDDenny BT. Getting better over time: A framework for examining the impact of emotion regulation training. Emotion. 2020 Feb;20(1):110-114. doi: 10.1037/emo0000641.
PMID: 31961188BACKGROUNDButler, M., J.E. Gaugler, K.M.C. Talley, H.I. Abdi, P.J. Desai, S. Duval, M.L. Fort, V.A. Nelson, W. Ng, J.M. Ouellette, E. Ratner, J. Saha, T. Shippee, B.L. Wagner, T.J. Wilt, and L. Yeshi, Care Interventions for People Living With Dementia and Their Caregivers. Comparative Effectiveness Review No. 231. (Prepared by the Minnesota Evidence-based Practice Center under Contract No. 290-2015- 00008-I.) AHRQ Publication No. 20-EHC023. 2020: Rockville, MD.
BACKGROUNDBrewster P, Barnes L, Haan M, Johnson JK, Manly JJ, Napoles AM, Whitmer RA, Carvajal-Carmona L, Early D, Farias S, Mayeda ER, Melrose R, Meyer OL, Zeki Al Hazzouri A, Hinton L, Mungas D. Progress and future challenges in aging and diversity research in the United States. Alzheimers Dement. 2019 Jul;15(7):995-1003. doi: 10.1016/j.jalz.2018.07.221. Epub 2018 Sep 19.
PMID: 30240574BACKGROUNDBoots LM, de Vugt ME, van Knippenberg RJ, Kempen GI, Verhey FR. A systematic review of Internet-based supportive interventions for caregivers of patients with dementia. Int J Geriatr Psychiatry. 2014 Apr;29(4):331-44. doi: 10.1002/gps.4016. Epub 2013 Aug 20.
PMID: 23963684BACKGROUNDSchulz R. The Future of Caregiver Efficacy Research: Commentary on "Long-Term Outcomes of the Benefit-Finding Group Intervention for Alzheimer Family Caregivers". Am J Geriatr Psychiatry. 2019 Sep;27(9):995-997. doi: 10.1016/j.jagp.2019.04.001. Epub 2019 Apr 10. No abstract available.
PMID: 31031074BACKGROUNDGodwin KM, Mills WL, Anderson JA, Kunik ME. Technology-driven interventions for caregivers of persons with dementia: a systematic review. Am J Alzheimers Dis Other Demen. 2013 May;28(3):216-22. doi: 10.1177/1533317513481091. Epub 2013 Mar 25.
PMID: 23528881BACKGROUNDBerking M, Ebert D, Cuijpers P, Hofmann SG. Emotion regulation skills training enhances the efficacy of inpatient cognitive behavioral therapy for major depressive disorder: a randomized controlled trial. Psychother Psychosom. 2013;82(4):234-45. doi: 10.1159/000348448. Epub 2013 May 22.
PMID: 23712210BACKGROUNDBerking M, Wupperman P, Reichardt A, Pejic T, Dippel A, Znoj H. Emotion-regulation skills as a treatment target in psychotherapy. Behav Res Ther. 2008 Nov;46(11):1230-7. doi: 10.1016/j.brat.2008.08.005. Epub 2008 Aug 30.
PMID: 18835479BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bryan Denny, Ph.D.
William Marsh Rice University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 10, 2023
First Posted
July 17, 2023
Study Start
September 14, 2023
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- De-identified data will be made available after the analysis process is complete and research manuscripts are finalized. There is no fixed end date for data access.
- Access Criteria
- Data will be publicly available on the Open Science Framework (https://osf.io), a free, open-science data repository.
Pursuant to the NIH Data Sharing Policy, we have created a Data Sharing Plan for the project. Under this plan, and pursuant to IRB regulations at Rice University and Baylor College of Medicine, fully de-identified raw data (defined below) will be made publicly available through the mechanisms below after the analysis process is complete and research manuscript(s) are finalized. Available data will include a compendium of de-identified training condition assignments; raw (i.e. individual subject-by-condition level) negative affect self-reports; ecological momentary assessment (EMA) reports; questionnaire data; and raw heart rate variability data. All datafiles will be uploaded to the Open Science Framework, a free, open-science data repository.